This seminar will help you understand in detail the application of FDA’s 21 CFR Part 11 guidance on electronic records/electronic signatures (ER/ES) for computer systems subject to FDA regulations. This is critical in order to develop the appropriate validation strategy and achieve the thoroughness required to prove that a system does what it purports to do. It also ensures that a system is maintained in a validated state throughout its entire life cycle, from conception through retirement.

ER/ES capability can vary, and the approach should be based on the specific case and the risk of failing to meet the guidance associated with it.

Develop the ability to apply 21 CFR Part 11 when implementing, validating and maintaining computer systems in your organization

Understand the best practices for maintaining a computer system with ER/ES capability in a validated state

Discuss the best practices necessary to ensure all systems with ER/ES capability are validated appropriately

Learn how to develop the appropriate computer validation strategy, to ensure a good balance of cost vs. risk, as it applies to the use of ER/ES capability

Understand how to effectively document the process of computer system validation where ER/ES capability exists, and maintain current information about the various systems in your organization and how they are maintained in a validated state

Learn how to gain information about trends in ER/ES validation, as industry progresses and new best practices emerge

Understand some of the key “pitfalls” to avoid when employing ER/ES capability

Interactive Q&A Session

Who Will Benefit:

This webinar is intended for those working in the FDA-regulated industries, including pharmaceutical, medical device, biological, animal health and tobacco. Functions that are applicable include research and development, manufacturing, Quality Control, distribution, clinical testing and management, adverse events management and post-marketing surveillance.

You should attend this webinar if you are responsible for planning, executing or managing the implementation of any system governed by FDA regulations, or if you are maintaining or supporting such a system. Examples of who will benefit from this webinar include:

Compliance and Audit Managers

Information Technology Analysts

Information Technology Developers and Testers

QC/QA Managers and Analysts

Clinical Data Managers and Scientists

Analytical Chemists

Laboratory Managers

Automation Analysts

Computer System Validation Specialists

GMP Training Specialists

Business Stakeholders/Subject Matter Experts

Business System/Application Testers

FDB2047

Carolyn Troiano

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects.

During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA’s electronic record/electronic signature regulation.

Carolyn has participated in industry conferences. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI’s Educational Fund as a project management instructor for non-profit organizations.

Refund Policy

Webinar Compliance reserves the right to cancel or reschedule any Webinar/event due to inevitable reasons such as insufficient registrations or circumstances beyond its control. All the attendees will be notified about the cancellation of the event, 24 hours prior to the start time of the Webinar event.

The cancelled Webinar, could be rescheduled and a New Date would be promptly intimated to the attendees.

In such an event, the attendee can opt for one of the below :

If the New Date is not of convenience, the webinar stream (1-Time Recording) may be availed.

The attendees may also opt to take a different webinar, which has a same price tag at a future date & time; they are welcome to do so.

On-Demand recordings (Past events) in exchange but equal to the original amount remitted.

A redeemable voucher (Valid for 12 months), which could be used to purchase any of our future events.

Webinar Compliance will process refund only if an event that has been cancelled, is not rescheduled within 90 days from the original scheduled date of the webinar.

If a webinar is canceled completely, an attendee may opt either of above points 2,3,4, or a full refund of the amount paid in a single settlement. The payment will be processed within 7 Business days from the day, we receive the refund request. However, Webinar Compliance will not be responsible for any penalties or other expenditure incurred due to the cancellation.

​Individual attendees can cancel their event for any specific reason. They must notify Webinar Compliance about the cancellation of their registration at least 48 hours prior to the event start date and time.

If the attendee fails to cancel the registration to the event within the above mentioned stipulated time or if fails to attend the event, no refund shall be made.

​

​For further clarification on the refund or cancellation policy, you can contact the support team over the phone or please write to us on support@webinarcompliance.com, with the transaction ID, event ID & event date in the subject column.